Empagliflozin for New On-set Heart Failure Study Regardless of Ejection Fraction

Sponsor
Chinese University of Hong Kong
Study ID
NCT05556044
Phase
PHASE3
Status
Unknown

Conditions

  • Acute Heart Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    This is an investigator-initiated, prospective, single-centre, non-randomized open label study that evaluates the efficacy and safety of initiating empagliflozin during index hospitalization for acute heart failure regardless of LVEF.

Study Details

Heart failure (HF) is one of the most important reasons for hospital admission and is associated with high mortality and morbidity. After discharge, up to 40% of patients are readmitted within 6 months and 1-year post-discharge mortality is high. The cost burden of treating patients with HF is high and \~80% of healthcare costs are related to hospital admissions. Sodium-glucose cotransporter-2 (SGLT2) inhibitor is considered one of the four foundational therapies (ACE-I or ARNI, beta-blockers, MRA, and SGLT2 inhibitors) for HFrEF. In particular, empagliflozin has been shown in randomized controlled trials to reduce the combined risk of cardiovascular death or HF hospitalization in HF patients with both reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF). However, guidelines do not specify the sequence and the timing of which therapy to be commenced. The timing of SGLT inhibitors initiation in the treatment of acute HF is not established. In particular, new-onset acute HF is a group which is understudied in the major trials to date. This study aims to evaluate the efficacy and safety of in-hospital initiation of empagliflozin in patients hospitalized for new onset acute HF, regardless of LVEF for up to 90 days of follow-up.

Key Dates

Start date
Sep 27, 2022
Status verified
Feb 2024
Primary completion
Feb 28, 2024
Completion
May 31, 2024

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Empagliflozin 10 MG

Primary Outcome Measure

Heart failure (HF) events [ Time Frame: 90 days ]

Central Contacts

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